The Journey of Bringing a Medical Device to Market
Bringing a medical device to market is never just a technical challenge. It’s a cross-functional journey that blends innovation, regulation, stakeholder alignment, and commercial strategy often with limited runway and plenty of uncertainty.
In this FMMC panel, Justin Bushko set the stage for an honest discussion on what happens between early concept and real commercialization. The group shared practical examples, startup realities, and FDA perspective to help teams navigate the path with fewer surprises.
From Startup Reality to Commercialization
Justin opened the panel by framing the discussion around real-life examples and the “Valley of Death”, the difficult gap between “promising idea” and “commercialized product.” The conversation centered on what it actually takes to move a device forward: understanding regulations, building user-centric design, aligning stakeholders, and planning for what comes next after development milestones.
The panel also highlighted EMIS Immersive as a real startup case study showing how early validation, iteration, and strategic choices can shape a product’s path to market. Real-World Validation
Clinical testing is a cornerstone of regulatory approval and market credibility. From preclinical studies to large-scale human trials, clinical data demonstrates that a device performs safely and effectively outside of controlled design environments. These studies help prove that a product is more than a strong concept, it works in real-world conditions.
An organized approach is essential to successful clinical testing. Partnering with experienced clinical research organizations and leveraging digital tools for patient recruitment can significantly reduce complexity. Strong planning and collaboration help generate the evidence needed to support both regulatory submissions and market adoption
EMIS Immersive and Patient-First Imaging
Adam Eisley, CEO and founder of EMIS Immersive, shared the vision behind immersive patient medical records. The product takes 3D medical imaging data and renders it into an interactive anatomical model, making it easier for non-clinicians to understand what they’re seeing. Instead of a confusing series of “slices,” the goal is to give patients a clearer view of what’s happening in their bodies, alongside their physician.
Adam shared early feedback that reinforced the need: patients described traditional MRI views as confusing, while the 3D rendering was significantly easier to understand. The discussion also touched on differentiation, including the ability to use multiple simultaneous “transfer functions” to highlight or suppress different tissue densities bringing more clarity without replacing clinical interpretation.
FDA Perspective and the TAP Program
Kai Catwitch, from the FDA’s Total Product Life Cycle Advisory Program (TAP), emphasized that regulatory readiness starts with the basics: device classification, regulatory pathway (510(k), De Novo, PMA), and understanding product codes and applicable regulations. A major theme was simple but critical companies often wait too long to interact with FDA. Early and frequent engagement through mechanisms like the Q-sub program can prevent expensive missteps, including invalid testing approaches or clinical studies that fail to demonstrate the right endpoints.
Kai also highlighted that FDA approval is only one part of success. Reimbursement planning, stakeholder incentives, and understanding how utilization and purchasing actually happen can determine whether a device thrives or stalls even after regulatory progress.
What Great Teams Do Differently: Stakeholders, Strategy, and Runway
Justin shared that companies often succeed when they define strong requirements early, test assumptions with real users, and prioritize risk reduction over appearance or “investor demo” prototypes. The panel reinforced that building the right thing is as important as building it right—user feedback and stakeholder alignment (clinicians, payers, patients, procurement, IT) must happen earlier than most teams expect.
Adam added a startup perspective: every decision is a tradeoff between speed, affordability, runway, and market pathway. The conversation underscored a key point, technical success and regulatory approval matter, but they don’t guarantee adoption. The strongest teams treat commercialization planning, reimbursement, and user-centric iteration as core development work, not side tasks.
Justin Bushko
President, Concise Engineering
Next Steps
We hope you find this newsletter valuable and insightful.
If you have any questions, if you have feedback or would like to explore any specific topics further, please feel free to reach out to us.
Please email me at jbushko@concise-engineering.com or to book a call with me, click this link.
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